Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma
May 13 2020 - 5:01PM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced new interim data from Cohort 2 in
the C-144-01 study of lifileucel in advanced melanoma. These data
will be part of an oral presentation at the American Society of
Clinical Oncology’s (ASCO) upcoming ASCO20 Virtual Scientific
Program, to be held May 29-31, 2020.
“We are very excited to share our latest melanoma data at the
upcoming ASCO oral presentation,” said Maria Fardis, Ph.D.,
president and chief executive officer of Iovance Biotherapeutics.
“The interim data as reported in the abstract continue to support
the durability of Iovance’s lifileucel TIL therapy, administered as
a one-time treatment for patients with advanced melanoma. As of
February 2020, the median duration of response had not been reached
at 17 months of median study follow up. We look forward to
providing additional updates during the oral presentation at the
ASCO20 Virtual Scientific Program.”
Updated interim results from Cohort 2 are available in the
abstract titled, “Long-term follow up of lifileucel (LN-144)
cryopreserved autologous tumor infiltrating lymphocyte therapy in
patients with advanced melanoma progressed on multiple prior
therapies.” As of the February 2, 2020 data cut off used for the
abstract submitted to ASCO20, lifileucel shows a 36.4% overall
response rate (n=66) and median duration of response (DOR) was not
reached at 17.0 months of median study follow up. The patients had
heavily pretreated metastatic melanoma with high baseline disease
burden. They have progressed on multiple prior therapies (3.3 mean
prior therapies), including anti-PD1 and BRAF/MEK inhibitors. The
adverse event profile was consistent with the underlying advanced
disease, lymphodepletion and IL-2 regimens. The abstract is
available in the ASCO Meeting Library at
https://meetinglibrary.asco.org.
Further updates will be available during the oral presentation
at the ASC20 Virtual Scientific Program. Details of the
presentation are as follows:
Title: Long-term follow up of lifileucel
(LN-144) cryopreserved autologous tumor infiltrating lymphocyte
therapy in patients with advanced melanoma progressed on multiple
prior therapiesAuthors: Amod Sarnaik, et
al.Session Title: Melanoma/Skin
CancersSession Type: Oral Abstract
SessionAbstract Number:
10006Location: ASCO20 Virtual Scientific Program
at
https://meetings.asco.org/am/virtual-programDate/Time:
available for on-demand viewing starting at 8:00am ET on May 29,
2020
About Iovance
Biotherapeutics, Inc. Iovance Biotherapeutics aims to
improve patient care by making T cell-based immunotherapies broadly
accessible for the treatment of patients with solid tumors and
blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a
patient’s own immune cells to attack cancer. TIL cells are
extracted from a patient’s own tumor tissue, expanded through a
proprietary process, and infused back into the patient. After
infusion, TIL reach tumor tissue, where they attack tumor cells.
The company has completed dosing in the pivotal study in patients
with metastatic melanoma and is currently conducting a pivotal
study in patients with advanced cervical cancer. In addition, the
company’s TIL therapy is being investigated for the treatment of
patients with locally advanced, recurrent or metastatic cancers
including head and neck and non-small cell lung cancer. A clinical
study to investigate Iovance T cell therapy for blood cancers
called peripheral blood lymphocyte (PBL) therapy is open to
enrollment. For more information, please visit www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are
“forward-looking statements” of Iovance Biotherapeutics, Inc.
(hereinafter referred to as the “Company,” “we,” “us,” or “our”)
within the meaning of the Private Securities Litigation Reform Act
of 1995. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. The
forward-looking statements include, but are not limited to, risks
and uncertainties relating to the success, timing, projected
enrollment, manufacturing and production capabilities, and cost of
our ongoing clinical trials and anticipated clinical trials for our
current product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe), such as
statements regarding the timing of initiation and completion of
these trials; the timing of and our ability to successfully submit,
obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, our product candidates, including
those product candidates that have been granted breakthrough
therapy designation (“BTD”) or regenerative medicine advanced
therapy designation (“RMAT”) by the FDA and new product candidates
in both solid tumor and blood cancers; the strength of the
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
Company’s ability to obtain tax incentives and credits; the
guidance provided for the Company’s future cash, cash equivalents,
short term investment and restricted cash balances; the success of
the Company’s manufacturing, license or development agreements; the
acceptance by the market of the Company’s product candidates, if
approved; and other factors, including general economic conditions
and regulatory developments, not within the Company’s control. The
factors discussed herein could cause actual results and
developments to be materially different from those expressed in or
implied by such statements. Actual results may differ from those
set forth in this press release due to the risks and uncertainties
inherent in the Company’s business, including, without limitation:
the COVID-19 pandemic may have an adverse effect on the Company and
its clinical trials, including potential slower patient
recruitment, inability of clinical trial sites to collect data,
inability of the Company or its contract research organizations to
monitor patients, as well as FDA availability due to competing
priorities; the preliminary clinical results, which may include
efficacy and safety results, from ongoing Phase 2 studies may not
be reflected in the final analyses of these trials or subgroups
within these trials; a slower rate of enrollment may impact the
Company’s clinical trial timelines; enrollment may need to be
adjusted for the Company’s trials and cohorts within those trials
based on FDA and other regulatory agency input; the new version of
the protocol which further defines the patient population to
include more advanced patients in the Company’s cervical cancer
trial may have an adverse effect on the results reported to date;
the data within these trials may not be supportive of product
approval; changes in patient populations may result in changes in
preliminary clinical results; the Company’s ability or inability to
address FDA or other regulatory authority requirements relating to
its clinical programs and registrational plans, such requirements
including, but not limited to, clinical, safety, manufacturing and
control requirements; the Company’s interpretation of
communications with the FDA may differ from the interpretation of
such communications by the FDA; risks related to the Company’s
ability to maintain and benefit from accelerated FDA review
designations, including BTD and RMAT, which may not result in a
faster development process or review of the Company’s product
candidates (and which may later be rescinded by the FDA), and does
not assure approval of such product candidates by the FDA or the
ability of the Company to obtain FDA approval in time to benefit
from commercial opportunities; the ability or inability of the
Company to manufacture its therapies using third party
manufacturers or its own facility may adversely affect the
Company’s potential commercial launch; the results of clinical
trials with collaborators using different manufacturing processes
may not be reflected in the Company’s sponsored trials; and
additional expenses may decrease our estimated cash balances and
increase our estimated capital requirements. A further list and
description of the Company’s risks, uncertainties and other factors
can be found in the Company’s most recent Annual Report on Form
10-K and the Company’s subsequent filings with the Securities and
Exchange Commission. Copies of these filings are available online
at www.sec.gov or www.iovance.com. The forward-looking statements
are made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
CONTACTS:Iovance Biotherapeutics,
Inc:Sara Pellegrino, IRCVice President, Investor Relations
& Public Relations650-260-7120 ext.
264Sara.Pellegrino@iovance.com
Solebury Trout:Annie Chang
(investors)646-378-2972achang@troutgroup.com
Chad Rubin (investors)646-378-2947crubin@troutgroup.com
Rich Allan (media)646-378-2958rallan@troutgroup.com
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